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EliA M2 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to M2 in human serum and plasma (Li-heparin, EDTA) to aid in the clinical diagnosis of primary biliary cirrhosis in conjunction with other laboratory and clinical findings. EliA M2 uses the EliA IgG method on the instrument Phadia 2500/5000.

The method-specific reagents are identical with K141375 (EliA M2 on Phadia 250), but are filled in containers specific for the Phadia 2500/5000 instrument. Each device consists of: - Test Wells: -EliA M2 Wells are coated with native pyruvate dehydrogenase complex from mitochondria and recombinant M2-antigen - 4 carriers (12 wells each), ready to use: - EliA Sample Diluent: PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 6 bottles, 48 mL each, ready to use; or 6 bottles, 400 mL each, ready to use; - EliA IgG Conjugate 50 or 200: ß-Galactosidase labeled anti-IgG (mouse monoclonal antibodies) in PBS containing BSA and 0.06% (w/v) sodium azide – 6 wedge shaped bottles, 5 mL each, ready to use; or 6 wedge shaped bottles, 19 mL each, ready to use - EliA IgG Calibrator Strips: Human IgG (0, 4, 10, 20, 100, 600 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 5 strips, 6 singleuse vials per strip, 0.3 mL each, ready to use; - -EliA IgG Curve Control Strips: Human IgG (20 ug/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 5 strips, 6 single-use vials per strip, 0.3 mL each, ready to use; - EliA IgG Calibrator Well: Coated with mouse monoclonal antibodies 4 carriers (12 wells each), ready to use. The Phadia EliA Immunodiagnostic System is an automated system for immunodiagnostic testing. The EliA reagents are available as modular packages, each purchased separately. All packages are required to carry out EliA M2 tests.

QUANTA Flash M2 (MIT3) is a chemiluminescent immunoassay for the semi-quantitative determination of IgG antimitochondrial antibodies in human serum. The presence of antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of primary biliary cholangitis. QUANTA Flash M2 (MIT3) Calibrators are intended for use with the QUANTA Flash M2 (MIT3) chemiluminescent immunoassay for the determination of IgG anti-mitochondrial antibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values. QUANTA Flash M2 (MIT3) Controls are intended for use with the QUANTA Flash M2 (MIT3) chemiluminescent immunoassay for quality control in the determination of IgG anti-mitochondrial antibodies in human serum.

The QUANTA Flash M2 (MIT3) assay is designed to run on the BIO-FLASH® instrument. This platform is a fully automated closed system with continuous load and random access capabilities that automatically processes the samples, runs the assay and reports the results. It includes liquid handling hardware, luminometer and computer with software-user interface. The QUANTA Flash M2 (MIT3) assay utilizes a reagent cartridge format, which is compatible with the BIO-FLASH instrument. Recombinant MIT3 antigen is coated onto paramagnetic beads. The bead suspension is lyophilized and stored in the bead tube. Prior to use in the BIO-FLASH system, the sealed reagent tubes are pierced with the reagent cartridge lid and the beads are rehydrated and resuspension buffer by pipetting up and down with a transfer pipette. The reagent cartridge is then loaded onto the BIO-FLASH instrument. Samples are also loaded onto the instrument in samples are diluted by the BIO-FLASH with system rinse in a small disposable plastic cuvette. Small amounts of the diluted patient serum, the beads, and assay buffer are combined into a second cuvette, and mixed. This cuvette is then incubated at 37°C. The beads are magnetized and washed several times. Isoluminol conjugated anti-human IgG antibodies are then added to the cuvette, and again incubated at 37°C. The beads are magnetized and washed repeatedly. The isoluminol conjugate is oxidized when Trigger 1 (Fe(II)coproporphyrin in sodium hydroxide solution) and Trigger 2 (urea-hydrogen peroxide in sodium chloride solution) are added to the cuvette, and the flash of light produced from this reaction is measured as Relative Light Units (RLU) by the BIO-FLASH optical system. The RLU are proportional to the amount of isoluminol conjugate that is bound to the human IgG, which is in turn proportional to the amount of anti-M2 (MIT3) antibodies bound to the corresponding beads. For quantitation, the QUANTA Flash M2 (MIT3) assay utilizes a predefined lot specific Master Curve that is uploaded onto the instrument through the reagent cartridge barcode. Every new lot number of reagent cartridge must be calibrated before first use, with the QUANTA Flash M2 (MIT3) Calibrators. Based on the results obtained with the three Calibrators included in the Calibrator Set (sold separately), an instrument specific Working Curve is created, which is used to calculate chemiluminescent units (CU) from the instrument signal (RLU) obtained for each sample. The QUANTA Flash M2 (MIT3) kit contains the following materials: One (1) QUANTA Flash M2 (MIT3) Reagent Cartridge One (1) vial of Resuspension buffer One (1) Transfer pipette The QUANTA Flash M2 (MIT3) reagent cartridge contains the following reagents for 50 determinations: - M2 (MIT3) coated paramagnetic beads, lyophilized. a. - b. Assay buffer - colored pink, containing Tris-buffered saline, Tween 20, protein stabilizers and preservatives. - Tracer IgG Isoluminol labeled anti-human IgG antibodies in buffer, containing protein C. stabilizers and preservative. The QUANTA Flash M2 (MIT3) Calibrators kit contains two vials each of Calibrator 2, and Calibrator 3: QUANTA Flash M2 (MIT3) Calibrators: - QUANTA Flash M2 (MIT3) Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human anti-mitochondrial antibodies in stabilizer and preservative. - -QUANTA Flash M2 (MIT3) Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human anti-mitochondrial antibodies in stabilizer and preservative. - -QUANTA Flash M2 (MIT3) Calibrator 3: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human anti-mitochondrial antibodies in stabilizer and preservative. The QUANTA Flash M2 (MIT3) Controls kit contains two vials of Negative Control and two vials of Positive Control: QUANTA Flash M2 (MIT3) Controls: - QUANTA Flash M2 (MIT3) Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human anti-mitochondrial antibodies in stabilizer and preservative. - QUANTA Flash M2 (MIT3) Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human anti-mitochondrial antibodies in stabilizer and preservative.

An enzyme linked immunosorbent assay (ELISA) for the qualitative detection of anti-mitochondria antibodies (AMA) in human serum to aid in the diagnosis of primary biliary cirrhosis (PBC) in conjunction with other laboratory tests and clinical findings. An enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of anti-mitochondria IgG antibodies in human serum to aid in the diary cirrhosis (PBC) in conjunction with other laboratory tests and clinical findings.

This test is performed as a solid phase immunoassy. Microwells are coated with recombinant Mitochondrial antigen. Controls, calibrators and patient sera are incubated in the antibodies present in the serum to bind to the Mitochondria antigen. Bound antibodies are detected by adding an enzyme labeled anti-human IgG or IgA/JgG/JgM conjugate. Specific enzyme substrate (TMB) is then added and the presence of antibodies is detected by a color change that is read by a spectrophotometer at 450 nm. Results are expressed in ELISA units per milliliter (EU/ml) and reported as positive or negative. This test is performed as a solid phase immunoassy. Microwells are coated with recombinant mitochondrial antigen. Controls, calibrators and patient sera are incubated in the antigen coated wells to allow specific antibodies present in the serum to bind to the Mitochondria antigen. Bound antibodies are detected by adding an enzyme labeled anti-human IgG or IgA/gG/lgM conjugate. Specific enzyme substrate (TMB) is then added and the presence of antibodies is detected by a color change that is read by a spectrophotometer at 450 nm. Results are expressed in ELISA units per milliliter (EU/ml) and reported as positive or negative.

EliA M2 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to M2 in human serum and plasma (heparin, EDTA) to aid in the clinical diagnosis of primary biliary cirrhosis in conjunction with other laboratory and clinical findings. EliA M2 uses the EliA IgG method on the instruments Phadia 100 and Phadia 250. EliA M2 Positive Control 100 is intended for laboratory use in monitoring the performance of in vitro measurement of M2 antibodies with Phadia 100 using the EliA IgG method. EliA M2 Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of M2 antibodies with Phadia 250 using the EliA IgG method.

The new device belongs to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using EliA single wells as the solid phase and is intended to be performed on the instruments Phadia 100 and Phadia 250. The conjugate for the EliA IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbelliferyl-ßD-Galactoside as substrate. The total IgG calibration is based on a set of six WHO-standardized IgG Calibrators derived from human serum. They are used to establish an initial calibration curve, which may be used for up to 28 days on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to recover in defined ranges to ensure that the stored calibration curve is still valid. The Fluorescence-Immunoassay test system includes test-, method-specific and general reagents that are packaged as separate units.

The EUROIMMUN EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG) kit is an immune line-blot strip test intended for the qualitative detection of IgG class antibodies against 8 different antigens: AMA-M2, M2-3E (BPO), Sp100, PML, gp210, LKM-1, LC-1 and SLA/LP in human serum and plasma (EDTA, Li-heparin, Citrate). Detection of these antibodies is used as an aid in the diagnosis of autoimmune liver diseases in conjunction with other laboratory and clinical findings.

The EUROIMMUN EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG) consists of antigen coated test strips, a positive control, alkaline phosphatase-labelled anti-human 1gG conjugate, sample buffer, wash buffer concentrate, NBT/BCIP substrate solution tray, test instruction, evaluation protocol and reaction control card.

The EUROIMMUN Anti-M2-3E ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IgG class autoantibodies against the mitochondrial antigens M2 in human serum and plasma. It is used as an aid in the diagnosis of primary billary cirrhosis (PBC), in conjunction with other laboratory and clinical findings.

The EUROIMMUN Anti-M2-3E ELISA (IgG) consists of a microwell ELISA plate coated with M2-3E antigen, 3 calibrators, positive and negative control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.

The QUANTA Lite™ PBC Screen IgG/IgA ELISA is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of mitochondrial antibodies, gp210 antibodies, and sp100 antibodies of the IgG and/or IgA class in human serum. The presence of mitochondrial, gp210, and sp100 antibodies of the IgG and/or IgA class can be used in conjunction with other clinical and laboratory findings to aid in the diagnosis of primary biliary cirrhosis.

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The QUANTA Lite™ M2 EP (MIT3) ELISA is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of mitochondrial antibodies in human serum. The presence of mitochondrial antibodies can be used in conjunction with clinical findings to aid in the diagnosis of primary biliary cirrhosis.

The QUANTA Lite™ M2 EP (MIT3) ELISA is an enzyme-linked immunosorbent assay (ELISA)

The QUANTA Lite™ sp100 kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of anti-sp100 antibody of the IgG class in human serum. This test is intended to aid in the diagnosis of primary biliary cirrhosis (PBC).

The QUANTA Lite™ sp100 kit is an enzyme-linked immunosorbent assay (ELISA).

The QUANTA Lite™ gp210 kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of anti-gp210 antibody of the IgG class in human serum. In an appropriate clinical context, results are intended to aid in the diagnosis of primary biliary cirrhosis (PBC).

The QUANTA Lite™ gp210 kit is an enzyme-linked immunosorbent assay (ELISA).